search
Back to results

Superficial Cervical Plexus Block for Postoperative Analgesia

Primary Purpose

Plexus Block;Analgesia;Neurosurgery

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Superficial cervical plexus block
Control group
Sponsored by
Beijing Tiantan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plexus Block;Analgesia;Neurosurgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Elective suboccipital retrosigmoid approach approach craniotomy;
  2. Age between 18 and 65 years;
  3. American Society of Anesthesiologists (ASA) physical status I-III.

Exclusion Criteria:

  1. The patients or legal clients refuse to provide informed consent;
  2. Local infection;
  3. Preoperative impairment of consciousness and cognitive function;
  4. Uncontrolled hypertension;
  5. Inability to communicate;
  6. Allergies to experimental drugs;
  7. History of drug abuse;
  8. History of chronic headache;
  9. Aphasia and hearing impairment;
  10. Patients undergoing second craniotomy;
  11. Body mass index < 18.5 kg/m2 or > 35.0 kg/m2;

Sites / Locations

  • Beijing Tiantan HospitalRecruiting
  • Beijing TianTan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Superficial cervical plexus block group

Control group

Arm Description

Outcomes

Primary Outcome Measures

the cumulative consumption of sufentanil by the PCA
the cumulative consumption of sufentanil by the PCA 24 hours after surgery

Secondary Outcome Measures

Use of analgesics by the PCA after operation
the cumulative consumption of sufentanil by PCA
Pain severity score
It will be accessed using NRS
Anesthesia recovery quality score：
It will be accessed at postoperative 1 and 2 hours using the Anesthesia Steward Emergence Scale. The Anesthesia Steward Emergence Scale(0-6) is divided into three parts: the degree of wakefulness - 2 points for complete recovery, 1 point for response to stimulation, 0 point for no response to stimulation; the degree of airway patency - 2 points for cough according to the doctor's order, 1 point for maintenance of airway patency without support, 0 point for support required for respiratory tract; 2 points for conscious activities of limbs with limb mobility, 1 point for unconscious activities of limbs, point for no activities of limbs.
Patient analgesic satisfaction
Patient satisfaction with overall pain management will be evaluated at 24 hours after surgery using NRS

Full Information

First Posted
July 26, 2019
Last Updated
September 9, 2021
Sponsor
Beijing Tiantan Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04036812
Brief Title
Superficial Cervical Plexus Block for Postoperative Analgesia
Official Title
Ultrasound Guided Superficial Cervical Plexus Block for Analgesia After Craniotomy Via Suboccipital Retrosigmoid Approach: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 18, 2019 (Actual)
Primary Completion Date
March 8, 2022 (Anticipated)
Study Completion Date
March 8, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tiantan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The incidence of postoperative pain after craniotomy is high. Severe postoperative pain can lead to a series of complications that are detrimental to the recovery of craniotomy patients. Compound local scalp nerve block is a good choice for analgesia after craniotomy. However, the scalp nerve block commonly cannot cover the area of suboccipital retrosigmoid approach craniotomy, leading to incomplete block. Superficial cervical plexus block (SCPB) is theoretically promising to solve the analgesia requirements of such surgical approach. At the same time, ultrasound guidance can not only accurately locate, ensure the effect of block and avoid accidental injury during puncture. The purpose of this study is to explore whether ultrasound-guided superficial cervical plexus block can safely and effectively reduce the requirement of analgesic drugs and pain after craniotomy via suboccipital retrosigmoid approach.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plexus Block;Analgesia;Neurosurgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Superficial cervical plexus block group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Sham Comparator
Intervention Type
Procedure
Intervention Name(s)
Superficial cervical plexus block
Intervention Description
superficial cervical plexus nerve block will be performed under the guidance of ultrasound
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
ultrasound guidance will be used to determine the location of superficial cervical plexus nerve. The puncture will also be performed by ultrasound guidance, covered with opaque infusion dressing but performed with infusion of 10 ml normal saline.
Primary Outcome Measure Information:
Title
the cumulative consumption of sufentanil by the PCA
Description
the cumulative consumption of sufentanil by the PCA 24 hours after surgery
Time Frame
24 hours after surgery
Secondary Outcome Measure Information:
Title
Use of analgesics by the PCA after operation
Description
the cumulative consumption of sufentanil by PCA
Time Frame
at 1, 2, 4, 48 hours after surgery.
Title
Pain severity score
Description
It will be accessed using NRS
Time Frame
at 1, 2, 4, 24, 48 hours after surgery
Title
Anesthesia recovery quality score：
Description
It will be accessed at postoperative 1 and 2 hours using the Anesthesia Steward Emergence Scale. The Anesthesia Steward Emergence Scale(0-6) is divided into three parts: the degree of wakefulness - 2 points for complete recovery, 1 point for response to stimulation, 0 point for no response to stimulation; the degree of airway patency - 2 points for cough according to the doctor's order, 1 point for maintenance of airway patency without support, 0 point for support required for respiratory tract; 2 points for conscious activities of limbs with limb mobility, 1 point for unconscious activities of limbs, point for no activities of limbs.
Time Frame
at 1 hour after surgery
Title
Patient analgesic satisfaction
Description
Patient satisfaction with overall pain management will be evaluated at 24 hours after surgery using NRS
Time Frame
at 24 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective suboccipital retrosigmoid approach approach craniotomy; Age between 18 and 65 years; American Society of Anesthesiologists (ASA) physical status I-III. Exclusion Criteria: The patients or legal clients refuse to provide informed consent; Local infection; Preoperative impairment of consciousness and cognitive function; Uncontrolled hypertension; Inability to communicate; Allergies to experimental drugs; History of drug abuse; History of chronic headache; Aphasia and hearing impairment; Patients undergoing second craniotomy; Body mass index < 18.5 kg/m2 or > 35.0 kg/m2;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuming Peng, M.D.
Phone
010-59976658
Email
florapym766@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuming Peng, M.D.
Organizational Affiliation
Beijing Tian Tan Hospital, Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuming Peng, M.D.
Facility Name
Beijing TianTan Hospital
City
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Completed

12. IPD Sharing Statement

Citations:
PubMed Identifier
35768167
Citation
Zeng M, Li R, Xu X, Wang D, Dong J, Li S, Kass IS, Peng Y, Jia W. Ultrasound-guided superficial cervical plexus block reduces opioid consumption in patients undergoing craniotomy via suboccipital retrosigmoid approach: a randomized controlled trial. Reg Anesth Pain Med. 2022 Jun 29:rapm-2022-103534. doi: 10.1136/rapm-2022-103534. Online ahead of print.
Results Reference
derived
PubMed Identifier
32029493
Citation
Peng K, Zeng M, Dong J, Yan X, Wang D, Li S, Peng Y. Ultrasound-guided superficial cervical plexus block for analgesia in patients undergoing craniotomy via suboccipital retrosigmoid approach: study protocol of a randomised controlled trial. BMJ Open. 2020 Feb 5;10(2):e034003. doi: 10.1136/bmjopen-2019-034003.
Results Reference
derived

Learn more about this trial

Superficial Cervical Plexus Block for Postoperative Analgesia

We'll reach out to this number within 24 hrs